About this trial
This is a single-center, single-arm, open investigator-initiated clinical study to evaluate the efficacy and safety of VRT106 in combination with chemotherapy in the treatment of resectable pancreatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
Males and females at 18-75 years of age, inclusive, at the Screening Visit.
Have a clinical diagnosis of pancreatic cancer.
An Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Disqualifiers
Prior treatment with other oncolytic virus or systemic therapy for pancreatic cancer.
Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
Immunocompromised patients.
Known alcohol or drug dependency.
Trial design
Single group
Treatments tested in this trial
Oncolytic virus VRT106
DrugVRT106, IV
Chemotherapy
Drug21 days/cycle, administered up to 6 cycles
Treatment groups
Trial outcomes
Primary outcomes
Safety and tolerability
Incidence rate of TRAE(Treatment-Related Adverse Event)
Secondary outcomes
Disease-free survival rate
Disease-free survival rates at 6, 12, 18, and 24 months
Sponsors and contacts
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Guangdong Provincial People's Hospital
Lead sponsor
Guangzhou Virotech Pharmaceutical Co., Ltd.
Collaborator